Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT04358003
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old
* Admitted to ICU
* Diagnosis of SARS-CoV-2 with any one of the following conditions:
1. Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
2. Severe disease, defined as:
1. dyspnea,
2. respiratory frequency ≥ 30/min
3. blood oxygen saturation ≤ 93%
4. partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or
5. lung infiltrates \> 50% within 24 to 48 hours; or
3. Life-threatening disease, defined as:
1. respiratory failure,
2. septic shock, and/or
3. multiple organ dysfunction or failure.
* Patient fact sheet is provided to the subject.
* Subject or legal representative is able and willing to give informed consent. If authorized by the IRB, emergent plasma adsorption with the D2000 cartridge may be initiated prior to consent.
Exclusion Criteria:
* Treatment limitation or a do not attempt to resuscitate in place
* Pregnancy
* Significant or uncontrolled bleeding
* In the opinion of the investigator, any other condition that precludes plasma adsorption with the D2000
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04358003
Study Brief:
Protocol Section:
NCT04358003